Biomaterial to Counteract Ridge Reduction Following the Removal of Multiple Adjacent Teeth. (Biomaterial)
Primary Purpose
Alveolar Ridge Trauma, Bone Resorption
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Bone grafting
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Ridge Trauma focused on measuring bone grafting, implantology, oral surgery
Eligibility Criteria
Inclusion Criteria:intact extraction sockets following removal of the natural teeth defined by:
- a marginal dehiscence defect of any of the facial bone walls of 3 mm
- no facial fenestration present in the apical of the marginal bone crest
Exclusion Criteria:
- untreated rampant caries and uncontrolled periodontal disease
- uncontrolled diabetes or any other systemic or local disease or condition that would compromise post-operative healing
- unable or unwilling to return for follow-up or unlikely to be able to comply with study procedures according to investigators judgement.
Sites / Locations
- Franci InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
bone grafting
natural healing
Arm Description
The possibility of counteracting unfavourable ridge modelling after multiple tooth extractions by placing bone grafting material in the fresh extraction sites.
ridge modelling after multiple tooth extractions.
Outcomes
Primary Outcome Measures
Cone Beam Computerized Tomographic (CBCT) examination at the center of each extraction socket, between the sockets, at the septum next to adjacent teeth.
Measurements of alveolar ridge dimensional changes in the first 6 months of healing
Secondary Outcome Measures
Standard intraoral radiograph of each experimental socket and inter-dental bone
Changes in crestal bone level between baseline (prosthetic restoration) and follow-up (3 years later)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02903667
Brief Title
Biomaterial to Counteract Ridge Reduction Following the Removal of Multiple Adjacent Teeth.
Acronym
Biomaterial
Official Title
Biomaterial to Counteract Ridge Reduction Following the Removal of Multiple Adjacent Teeth. A Prospective Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute Franci
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open, prospective, randomized, multicenter study focused on the ridge diminution in case of grafting of fresh extraction sockets with Bio-Oss Collagen, Bio-Gide (Geistlich Pharma, Wolhusen, Switzerland), placing Dentsply implants (Astra Tech System).
Detailed Description
The removal of at least 2 adjacent teeth would cause more advanced hard tissue loss during healing than that occurring after removal of a single tooth with adjacent teeth present. In order to maintain the dimension of the ridge following tooth removal, bone grafts and bone substitutes have also been placed in the extraction socket. So far no data have been reported on the effect of removal of multiple adjacent teeth on bone loss at various aspects of the edentulous sites. Furthermore, the potential effect on ridge contraction of implant placement in multiple fresh extraction sites is not documented. Therefore, the objective of the study is to evaluate the possibility of counteracting un favourable ridge modeling after multiple tooth extractions by placing mineral bovine bone in the extraction sockets and covering the wound with a native collagen membrane. In addition, the possibility of placing implants in the grafted sites is evaluated after six month of healing. For these purpose 40 subjects with 2 or more fresh adjacent extraction sites in need of two or more implants replacing teeth will be enrolled. Ridge dimensional changes will be measured after 6 months of healing; marginal bone loss will be measured after 3-years follow-up from the baseline (prosthetic delivery).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Ridge Trauma, Bone Resorption
Keywords
bone grafting, implantology, oral surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bone grafting
Arm Type
Experimental
Arm Description
The possibility of counteracting unfavourable ridge modelling after multiple tooth extractions by placing bone grafting material in the fresh extraction sites.
Arm Title
natural healing
Arm Type
Sham Comparator
Arm Description
ridge modelling after multiple tooth extractions.
Intervention Type
Device
Intervention Name(s)
Bone grafting
Primary Outcome Measure Information:
Title
Cone Beam Computerized Tomographic (CBCT) examination at the center of each extraction socket, between the sockets, at the septum next to adjacent teeth.
Description
Measurements of alveolar ridge dimensional changes in the first 6 months of healing
Time Frame
Up to 24 weeks
Secondary Outcome Measure Information:
Title
Standard intraoral radiograph of each experimental socket and inter-dental bone
Description
Changes in crestal bone level between baseline (prosthetic restoration) and follow-up (3 years later)
Time Frame
3 years follow up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:intact extraction sockets following removal of the natural teeth defined by:
a marginal dehiscence defect of any of the facial bone walls of 3 mm
no facial fenestration present in the apical of the marginal bone crest
Exclusion Criteria:
untreated rampant caries and uncontrolled periodontal disease
uncontrolled diabetes or any other systemic or local disease or condition that would compromise post-operative healing
unable or unwilling to return for follow-up or unlikely to be able to comply with study procedures according to investigators judgement.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Cecchinato, MD, DDS
Phone
+39049684336
Email
info@deniscecchinato.it
Facility Information:
Facility Name
Franci Institute
City
Padova
ZIP/Postal Code
35121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Cecchinato
Phone
+393473203900
Email
denis@denicecchinato.it
First Name & Middle Initial & Last Name & Degree
Enrico Corrà, DDS
First Name & Middle Initial & Last Name & Degree
Marco Toia, DDS
First Name & Middle Initial & Last Name & Degree
Denis Cecchinato, MD-DDS
First Name & Middle Initial & Last Name & Degree
Eriberto Bressan, DDs
First Name & Middle Initial & Last Name & Degree
Jan Lindhe, Prof.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Biomaterial to Counteract Ridge Reduction Following the Removal of Multiple Adjacent Teeth.
We'll reach out to this number within 24 hrs